BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1061394 · Received June 16, 2008

    Report

    Report Number
    9616099-2008-01526
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    April 9, 2008
    Report Date
    May 23, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    STENT DEPLOYMENT DIFFICULTY LED TO INACCURATE PLACEMENT. THE REPORT RECEIVED INDICATED THAT DURING IMPLANT OF THE 10X40 SMART CONTROL STENT, THE PHYSICIAN ENCOUNTERED DIFFICULTIES, AS THE "STENT JUMPED FORWARD" DURING DEPLOYMENT AND COULD NOT COVER THE WHOLE LESION. THEREFORE, ANOTHER STENT WAS DEPLOYED TO COVER THE LESION. NO OTHER COMPLICATIONS WERE REPORTED AND THE PT WAS REPORTED TO BE IN STABLE CONDITION. FURTHER INFO INDICATED THAT THERE WERE NO PROBLEMS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE, WHICH MAY HAVE CONTRIBUTED TO THE EVENT. IT WAS INDICATED THAT THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION AND THAT THE DELIVERY SYSTEM HAD BEEN ADVANCED PAST THE LESION AND THEN WITHDRAWN BACK INTO THE LESION PRIOR TO STENT DEPLOYMENT. IT WAS INDICATED THAT THE USER HELD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 13310369

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention